Enanta Pharmaceuticals Initiates Proof-of-Concept Study with Pan-genotypic Cyclophilin Inhibitor EDP-494 in Patients with Gen...
June 20 2016 - 10:46AM
Business Wire
- EDP-494 represents a new host-targeted
approach that may play an important role in future treatment
regimens for chronic hepatitis C virus (HCV) patients that have
failed therapy due to resistance arising from direct-acting
antiviral (DAA) therapies currently on the market
- New non-DAA mechanism retains potency
against important DAA resistance-associated variants (RAVs),
regardless of class
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases, today
announced that it has initiated a proof of concept study (POC) and
has begun dosing with EDP-494, a potent, pan-genotypic cyclophilin
inhibitor to treat patients with genotype 1 (GT1) or genotype 3
(GT3) chronic hepatitis C virus.
The double-blind, randomized POC portion of this ongoing phase 1
study will assess the safety, pharmacokinetics and anti-viral
activity of two planned different doses of EDP-494 in
treatment-naïve HCV patients dosed orally, once daily for 14 days.
Safety and pharmacokinetics of single and multiple ascending doses
of once daily, orally administered EDP-494 have been established in
healthy volunteers and these data support the testing of EDP-494 in
a proof-of-concept study in HCV patients.
EDP-494, a Cyclophilin Inhibitor for HCV Infection
Due to resistance arising with direct-acting antiviral HCV
therapies currently on the market, Enanta has developed an
alternative treatment approach to HCV that targets the human host
protein cyclophilin, which is essential for replication of HCV.
Since cyclophilin inhibitors act as host-targeted antivirals, the
viral mutation resistance that arises from direct-acting antiviral
(DAA) treatments would not be expected for this mechanism, and thus
cyclophilin inhibitors may have the highest barrier to resistance
of any class of HCV treatments.
“As the number of patients treated with the current HCV DAA
regimens on the market rapidly increases, the treatment failure
population will become an important unmet medical need in patients
with hepatitis C and may require new mechanisms of therapy such as
cyclophilin inhibition,” commented Professor Edward J. Gane, MD,
Professor of Medicine at the University of Auckland, New Zealand
and Chief Hepatologist, Transplant Physician and Deputy Director of
the New Zealand Liver Transplant Unit at Auckland City Hospital and
chief investigator of the EDP-494 study. “This host-targeted
approach may prove valuable not only in the toughest to treat
patients with DAA resistance, but also in the general HCV patient
population, given its pangenotypic mechanism of action and high
barrier to resistance.”
Data presented at the International Liver Congress™ 1 in
Barcelona in April, 2016 demonstrated that EDP-494 in replicon
assays is a potent inhibitor of HCV replication and has shown no
loss of potency against all major NS5A RAVs, NS5B RAVs (both
Nucleotide and non-Nucleotide) as well as NS3 protease inhibitor
RAVs.
Following the completion of the phase 1 study, Enanta plans to
develop EDP-494 in combination with one or more DAAs for the
treatment of any emerging HCV resistance to currently marketed
therapies or any other therapies in development that use DAAs.
Enanta anticipates that a DAA-cyclophilin inhibitor combination
could provide one of the highest barrier to resistance combination
treatments for HCV.
About EDP-494
EDP-494 is a cyclophilin inhibitor that targets the human host
protein, cyclophilin, which is essential for replication of chronic
hepatitis C virus (HCV). Host-targeted antivirals (HTAs) such as
cyclophilin inhibitors are not affected by changes in the virus
and, therefore, use of this class of inhibitor may provide a unique
solution for a subset of hard-to-treat HCV patients. Enanta has
demonstrated in replicon assays that EDP-494 is a potent inhibitor
of HCV. A phase 1 clinical study in HCV patients is currently
underway.
About Enanta
Enanta Pharmaceuticals is a research and development-focused
biotechnology company that uses its robust chemistry-driven
approach and drug discovery capabilities to create small molecule
drugs for viral infections and liver diseases. Enanta’s research
and development efforts are currently focused on four disease
targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV),
Non-alcoholic Steatohepatitis (NASH) and Respiratory Syncytial
Virus (RSV).
Enanta has discovered novel protease inhibitors and NS5A
inhibitors that are members of the direct-acting-antiviral (DAA)
inhibitor classes designed for use against the hepatitis C virus
(HCV). Enanta’s protease inhibitors, developed through its
collaboration with AbbVie, include paritaprevir, which is contained
in AbbVie’s marketed DAA regimens for HCV, and ABT-493, Enanta’s
second protease inhibitor, which AbbVie is developing in phase 3
studies in combination with ABT-530, AbbVie’s NS5A inhibitor.
Enanta has also discovered a cyclophilin inhibitor, EDP-494, a
novel host-targeting mechanism for HCV, which is now in phase 1
clinical development, and EDP-305, an FXR agonist, which Enanta
plans to advance into clinical development for NASH later in 2016.
Please visit www.enanta.com for more information on Enanta’s
programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the potential market for
patients with DAA-resistant HCV and the prospects for further
clinical development of EDP-494 for the treatment of HCV and its
RAVs. Statements that are not historical facts are based on
management’s current expectations, estimates, forecasts and
projections about Enanta’s business and the industry in which it
operates and management’s beliefs and assumptions. The statements
contained in this release are not guarantees of future performance
and involve certain risks, uncertainties and assumptions, which are
difficult to predict. Therefore, actual outcomes and results may
differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual
results include: the development risks of early stage clinical
trials of EDP-494; regulatory actions affecting approvals of new
HCV treatment regimens after recent approvals of new regimens and
anticipated submissions and approvals of other regimens currently
in late stage clinical development; the pricing, market acceptance
and reimbursement rates of competitive HCV treatment regimens on
the market and product candidates of other companies under
development; Enanta’s lack of clinical development experience;
Enanta’s need to attract and retain senior management and key
scientific personnel; Enanta’s need to obtain and maintain patent
protection for its product candidates and avoid potential
infringement of the intellectual property rights of others; and
other risk factors described or referred to in “Risk Factors” in
Enanta’s most recent Form 10-K for the fiscal year ended September
30, 2015 and other periodic reports filed more recently with the
Securities and Exchange Commission. Enanta cautions investors not
to place undue reliance on the forward-looking statements contained
in this release. These statements speak only as of the date of this
release, and Enanta undertakes no obligation to update or revise
these statements, except as may be required by law.
_______________________________________________________________
1 P-250. C. Owens et.al., “EDP-494 is a Potent Pan-Genotypic
Cyclophilin Inhibitor for HCV Infection, Including DAA Resistance
Associated Variance (DAAs)”. The 51st Annual Meeting of the
European Association for the Study of the Liver, The International
Liver Congress™, April 13-17, 2016 Barcelona, Spain.
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Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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